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Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

NCT ID: NCT00482248

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-06-30

Brief Summary

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This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma anti-immunoglobulin E omalizumab allergic asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Omalizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
* Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee

Exclusion Criteria

* Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
* Pregnant females or nursing mothers
* Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Other Identifiers

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CIGE0250011E3

Identifier Type: -

Identifier Source: org_study_id